This invention relates to a method and implant for treating urinary incontinence. It further relates to a positioning and delivery system and method for materials that can be implanted in the human body, particularly for the purpose of treating urinary incontinence.
Urinary incontinence is an inability to hold urine in the bladder until it is decided to release it. Millions of people, male and female, young and old, experience incontinence. Women are twice as likely to experience incontinence than men are. This is likely due to pregnancy and childbirth, menopause, and the structure of the female urinary tract. However, both men and women can experience incontinence due to strokes, multiple sclerosis, prostate surgery and old age. Urinary incontinence often occurs because of problems in the muscles that hold or release urine, such as sudden contraction of bladder muscles or sudden relaxation of the muscles surrounding the urethra.
There are many types of urinary incontinencexe2x80x94stress incontinence, urge incontinence, functional incontinence, overflow incontinence, transient incontinence, and mixed types of incontinence. Each of these is related to particular physical problems, such as weakened muscles, physical changes, physiological changes, neurological problems, and disease. However, all forms of urinary incontinence are treatable through a variety of surgical and non-surgical procedures.
Among the available non-surgical treatments are Kegel exercises, electrical stimulation of pelvic muscles, biofeedback, timed voiding, bladder training, and medications. Some choose to wear absorbent pads or undergarments. Another choice includes restricting certain liquids. However, each treatment has limited effectiveness and often potentially harmful side effects. For instance, Kegel exercises and electrical stimulation can reduce stress and urge incontinence. Biofeedback may relieve stress and urge incontinence. Medications can reduce certain types of leakage by inhibiting contractions or relaxing muscles. However, these treatments do not cure urinary incontinence. They tend only to alleviate the problem. Further, certain medications can have harmful side effects, such as the increased risk of breast and endometrial cancer associated with estrogen therapy.
Many surgical procedures are also available to treat urinary incontinence. Among the available procedures are pessaries, implants, bladder surgery, and catheterization. Surgical options include surgery to pull the bladder up to a more normal position, surgery to secure the bladder with a wide sling, or surgery to insert an artificial sphincter around the urethra. However, again, each has its own effectiveness rate and possible side effects. For example, one serious concern with the use of pessaries or long-term catheters is urinary tract infections.
Implants into the tissues around the urethra have a partial success rate, but raise concerns of allergic reactions to the implanted material. A commonly used product, Contigen TM, a bovine collagen injectable, can be applied via the perineum, transurethrally or transvaginally. This material provides adequate bulking but only lasts 6-9 months. Teflon (ptfe) paste is currently being explored as a potential bulking agent but has the drawback of consisting of small Teflon particles which may migrate from the position of their original placement in the body.
The present invention is directed to the use of implantable materials that provide bulking of the periurethral and sphenteric tissues near the bladder neck. The invention is further directed to methods of positioning and delivering such implantable materials. The materials used, and the methods by which they are delivered and positioned, provide a biocompatible implant that directly acts to treat female urinary incontinence. By using biocompatible materials, the body does not reject the implant and the implant provides permanent relocation of tissues in the soft tissue area around the urethra. By using materials of the specified size and shape, the implanted material is designed for the avoidance of migration from its original position in the body. The use of the described positioning and delivery system provides ease in accurately positioning the implant, resulting in better placement for treatment of incontinence.
Overall, the invention provides the ease of use of previous bulking agents, but has the advantage of persistent and more predictable bulking. Additionally, because the material is tubular and non-biodegradable, it is stabilized in soft tissue resulting in less migration.